Clinical Evaluation and Investigation of Medical Devices under the new EU-Regulation

Clinical Evaluation and Investigation of Medical Devices under the new EU-Regulation
Author :
Publisher : BoD – Books on Demand
Total Pages : 282
Release :
ISBN-10 : 9783751937665
ISBN-13 : 3751937668
Rating : 4/5 (668 Downloads)

Book Synopsis Clinical Evaluation and Investigation of Medical Devices under the new EU-Regulation by : Wolfgang Ecker

Download or read book Clinical Evaluation and Investigation of Medical Devices under the new EU-Regulation written by Wolfgang Ecker and published by BoD – Books on Demand. This book was released on 2020-06-04 with total page 282 pages. Available in PDF, EPUB and Kindle. Book excerpt: The concept of clinical evaluation and the framework for clinical investigations have been significantly enforced within the new EU-Medical Device Regulation (MDR). This book provides in-depth and practice-oriented guidance on the systematic identification and generation of clinical data through clinical investigations and other relevant sources. It addresses the needs of all stakeholders, be it manufacturers, notified bodies or competent authorities, when they have to plan, perform or assess clinical evaluations and investigations for medical devices on the way to conformity assessment and CE marking. It is a valuable tool of qualification for clinicians and related experts when preparing for a role of a clinical evaluator in the field, either when serving any of the stakeholders or when trying to make their own involvement stand out in start-ups. spin-offs or other development projects or in counselling services.


Clinical Evaluation and Investigation of Medical Devices under the new EU-Regulation Related Books

Clinical Evaluation and Investigation of Medical Devices under the new EU-Regulation
Language: en
Pages: 282
Authors: Wolfgang Ecker
Categories: Medical
Type: BOOK - Published: 2020-06-04 - Publisher: BoD – Books on Demand

DOWNLOAD EBOOK

The concept of clinical evaluation and the framework for clinical investigations have been significantly enforced within the new EU-Medical Device Regulation (M
The Challenges of Conducting Medical Device Studies
Language: en
Pages: 94
Authors: Keith Summerhayes
Categories: Clinical trials
Type: BOOK - Published: 2005 - Publisher: Inst of Clinical Research

DOWNLOAD EBOOK

Describing all the regulations, guidelines and directives that affect medical device studies.
A Comparative Analysis of Medical Device Regulations in the EU and the USA
Language: en
Pages: 80
Authors: Ann-Marie Jahn
Categories: Business & Economics
Type: BOOK - Published: 2016-01-12 - Publisher: GRIN Verlag

DOWNLOAD EBOOK

Bachelor Thesis from the year 2012 in the subject Economy - Health Economics, grade: First, Berlin School of Economics and Law, language: English, abstract: Inn
Medical Device Safety
Language: en
Pages: 192
Authors: G.R Higson
Categories: Medical
Type: BOOK - Published: 2001-10-29 - Publisher: CRC Press

DOWNLOAD EBOOK

Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety examines the prospects for achieving global harmonization in medical devic
The Development of Medical Devices
Language: en
Pages: 168
Authors: Dirk Lanzerath
Categories: Medical instruments and apparatus
Type: BOOK - Published: 2020 - Publisher:

DOWNLOAD EBOOK